Activity of Inspiratory Muscles With the Use of Positive Pressure in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dannuey Machado Cardoso, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01111487
First received: April 26, 2010
Last updated: September 25, 2011
Last verified: September 2011
  Purpose

The objective is to evaluate whether the use of expiratory positive airway pressure (EPAP) reduces the electrical activity of the sternocleidomastoid muscle and enhances the action of the muscle in the patient parasternal ported from Chronic Obstructive Pulmonary Disease. Noting also, if the set pressure level (10 or 15 cmH2O) affects this relationship.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Device: Expiratory positive airway pressure (EPAP) by face mask.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Recruitment in COPD Patients With the Use of Expiratory Positive Airways Pressure

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Electromyographic activity of muscles and sternocleidomastoid parasternal [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    An average baseline, before the use of expiratory positive airway pressure (EPAP) to be compared with two-mediated during the 20 minutes of application of EPAP and 10 minutes after its removal.


Estimated Enrollment: 40
Study Start Date: November 2009
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group I
This group will use a pressure level of 10 cmH2O.
Device: Expiratory positive airway pressure (EPAP) by face mask.
Implementation of the EPAP as group pressure, 10 or 15 cmH2O, for 20 minutes then evaluated the electromyographic activity of muscles and sternocleidomastoid parasternal the tenth and twentieth minutes of your application.
Other Name: PEP-mask
Active Comparator: Group II
This group will use a pressure level of 15 cmH2O.
Device: Expiratory positive airway pressure (EPAP) by face mask.
Implementation of the EPAP as group pressure, 10 or 15 cmH2O, for 20 minutes then evaluated the electromyographic activity of muscles and sternocleidomastoid parasternal the tenth and twentieth minutes of your application.
Other Name: PEP-mask

Detailed Description:

The chronic obstructive pulmonary disease (COPD) is characterized by chronic obstruction to airflow, which leads to respiratory muscle overload and greater activation of accessory muscles of respiration, especially those active in the inspiratory phase. It is believed that the positive expiratory pressure (EPAP) reduces respiratory work, producing less activation of these muscles. Thus, we evaluate the behavior of the electrical activity of inspiratory muscles of COPD patients in response to application of expiratory positive airway pressure (EPAP), and to observe the influence of pressure level in inspiratory muscle recruitment. This will be implemented for a clinical single blinded trial (blinded to gauge the outcome) developed in the Department of Pneumology, Hospital de Clinicas de Porto Alegre (HCPA). Will be evaluated in COPD patients with a clinical diagnosis of pathology, and of both genders and should be aged between 40 and 70 years. In a first day will be collected anthropometric data, performed the lung function test for the staging of pathology and muscle strength testing. These same individuals will return to evaluate the electromyographic activity of sternocleidomastoid (SCM), and parasternal, both from the right hemisphere. This evaluation will consist in the measurement during breathing at rest (control), with the implementation of EPAP mask 10 or 15 cmH2O (state intervention) and 10 minutes after its removal. To test the lung function will be assessed using a spirometer and the lung capacity compared to the predicted in literature. As the electrical activity of muscle, will be observed the percentage of activation obtained for the highest activity (% RMS). Thus, it is expected that the implementation of EPAP promotes reduction of the electrical activity of muscle ECM and leverage the action of the parasternal muscle, affected by dynamic hyperinflation. It is also hoped that the use of blood pressure level of 15 cmH2O, compared to 10 cmH2O, the leverage effect of EPAP on the muscles of interest. The surface electromyographic evaluation is a method of relatively inexpensive and noninvasive, and is effective in evaluating the electrical potential that lies on the muscle membrane. So, will describe the effect of EPAP on the inspiratory muscles, which will be important to guide treatment of COPD patients using positive airway pressure therapy.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of COPD in stage II or III according to classification of the Global Initiative for Chronic Obstructive Lung Disease (GOLD);
  • Signing the consent form;
  • Stability of clinical pathology, with no signs of exacerbation in the 30 (thirty) days prior to the inclusion in the study.

Exclusion Criteria:

  • Individuals would use artificial airway;
  • Hemodynamic instability;
  • Body mass index (BMI) above the values considered as obese (> 30Kg/m2).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01111487

Locations
Brazil
HCPA - Hospital of Clinicas of Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90040-060
University of Santa Cruz do Sul
Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96815-900
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Sérgio S Menna Barreto, Dr Hospital of Clinicas of Porto Alegre
  More Information

Publications:

Responsible Party: Dannuey Machado Cardoso, Post graduation, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01111487     History of Changes
Other Study ID Numbers: 09-500
Study First Received: April 26, 2010
Last Updated: September 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Hospital de Clinicas de Porto Alegre:
COPD
Electromyography
Inspiratory muscles

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014